Evaluation of Contact Lens Saline Solutions With Scleral GP Contact Lens Wearers Experiencing Fogging
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Patient Subjective Symptoms and Wear Time Survey
研究概览
简要总结
Evaluation of saline solutions used with scleral rigid gas permeable contact lens wearers experiencing debris in the post lens tear reservoir
详细描述
One-month, approximately 36 subjects enrolled (~12/site), randomized, double-masked crossover trial.
Existing scleral rigid gas permeable (RGP) contact lens wearing subjects are randomly assigned (block) to different arms of the trial and receive different saline solutions for use sequentially for 2-week periods. The subjects will continue to wear their existing scleral GP lenses if lens fit is acceptable following an initial evaluation. Subjects will agree to complete a survey administered daily (via email) that will address contact lens wear time and subjective symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Randomized, Double-Masked
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Daily wear large diameter (scleral) rigid gas permeable contact lens wearers in design with acceptable fit
- •18 years old or above.
- •Agree to and sign Informed Consent.
- •Correctable to at least 20/40 distance visual acuity in each eye.
- •Presence of debris or "fogging" in post lens tear film reservoir (PLTR).
排除标准
- •Extended wear contact lens wearers
- •Require concurrent ocular medication.
- •Grade 2 or more slit lamp findings (does not include fogging assessment).
- •Eye injury or surgery within twelve weeks immediately prior to enrolment for this trial.
- •Currently enrolled in an ophthalmic clinical trial.
- •Pregnant or lactating
- •Evidence of active ophthalmic disease or abnormality including glaucoma, chorioretinitis, central retinal artery or vein occlusion, intraocular or ocular infection.
结局指标
主要结局
Patient Subjective Symptoms and Wear Time Survey
时间窗: 1 Month
Participant Survey on Lens Comfort (based on a scale of 0 to 5), Symptoms (graded based on frequency (rarely/sometimes/often/always) and severity(slight/moderate/severe)), Total Wear Time (reported as hours per day) and How Many Times Lenses are Removed Daily (reported as number of times per day)
次要结局
- Visual Acuity(1 Month)
- Biomicroscopy Findings(1 Month)